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Director Quality Assurance Regulatory Affairs

1 month ago

Beverly, United States Norconsulting Global Recruitment Full time

Title: Director Quality Assurance Regulatory Affair

Location: Massachusetts

This is a hybrid role requires 4 days in the office per week with one remote day.

Key Qualifications and Experience:

• Regulatory Expertise: Thorough understanding of FDA cGMP/QSR, ISO standards, MDSAP, EU MDR/IVDR, and CMDR. Proficient in regulatory submissions (Pre-submissions, 510(k), PMA, Technical Files, etc.) and international product registrations.

• Quality Management: Extensive experience in Quality Control, Assurance, Auditing, and System Management, with a deep knowledge of ISO 13485 and ISO 14971.

• Industry Experience: 7+ years in Quality Management, Assurance, and Regulatory Affairs in the medical device industry, with 3-5 years of managerial experience.

• Technical Skills: Familiarity with electromechanical equipment, eQMS, ERP, and Microsoft Office applications.

• Educational Background: Bachelor's degree in a scientific field (preferably engineering, life sciences, or regulatory discipline); a higher degree and RAC or equivalent certification are preferred.

• Additional Skills: Strong organizational, communication, and collaborative abilities, with a hands-on approach to detailed work.